RP-6: Calibration Quality Systems for the Healthcare Industry

As many of you know, I’ve long been involved with NCSL International (NCSLI) in a number of capacities; one of which has been the upkeep of one of the organization’s guidance documents, Recommended Practice – 6 (RP-6). My first activity with the document was on the third edition in 2008. Most recently, I have played an active role in the latest revision in 2015.

What is RP-6?

RP-6 is published by NCSLI with specific focus on the Healthcare Metrology Industry. NCSLI has a number of technical committees ranging from Healthcare to Automotive to Aerospace; many having respective Recommended Practices for their industries.

The official title, Calibration Quality Systems for the Healthcare Industry, does well to detail the area of quality management it covers and the goes into a bit more detail on the standard:

NCSL International Recommended Practice 6 is intended to provide general guidance that can be used by healthcare industry organizations to establish an effective calibration quality system. This recommended practice is intended for use by any healthcare industry organization that engages in the calibration of M&TE. This document can be used to develop calibration quality systems for healthcare industry organizations in order to ensure that M&TE are adequately calibrated to meet regulatory and quality requirements. The healthcare industry is committed to providing products and services of the highest possible quality and integrity to the world healthcare market. Thus, a calibration quality system should be established. The original Recommended Practice was developed by the Biomedical and Pharmaceutical Metrology Committee of the NCSL International (NCSLI). This latest revision by the Healthcare Metrology Committee reflects current international standards and regulatory requirements.

Source: This document can be found at NCSL International.

Additions to RP-6

Now on its fourth revision, these new topics help place focus on the product and manufacturing processes. Measurement is the decision maker when it comes to conformance of a product or subassemblies against their intended design. The addition of Appendix B is of particular value for the calibration laboratory when having M&TE adequacy discussions with equipment and process owners.

Further additions include:

  • Instrument Classification
  • Equipment Storage and Handling
  • Adequacy of M&TE for Intended Use Decision

In this revision, a writing group was formed by 16 participants representing our industry.  Commencement began in November 2013. Nearly two years late, the final working document was voted and approved by the NCSLI Board of Directors in October, 2015.

From the perspective of many who participated in required periodic reviews, the document did not initially appear to require a revision effort. Over time, analyzing this document in further detail presented us with improvements that could be made. In result, new sections were added and extant content was edited.

I am proud of the efforts put forward by our team to provide a top-quality guidance document for Healthcare Metrology. It truly reflects the efforts of some of the most talented and seasoned individuals in our global industry. I applaud Walter Nowocin of Medtronic, Inc. for his efforts in leading this revision. RP-6 is a very worthwhile reference in any Healthcare Metrology quality system and is of particular interest to anyone tasked with setting up a Metrology/Calibration Program.

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